Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

Topical Diclofenac for the Treatment of Noncyclic Breast Pain

The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

Study Overview

• Status: Terminated
• Conditions: Breast Pain; Non-cyclical Mastalgia; Surgical Scar-Related Breast Pain
• Intervention / Treatment: Drug: Diclofenac; Drug: Placebo

Detailed Description

A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria

• Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
• Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
• Age > 18 years
• Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
• Satisfactory mammogram (all women > 30 years of age) within 12 months
• Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)

Exclusion criteria

• Cyclic mastalgia (as defined above)
• Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
• Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
• Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
• Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
• Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
• Rash or open lesions at the site on the breast where the topical agent would be applied
• Incomplete or abnormal healing (surgical scar-related pain)
• History of gastrointestinal ulceration, renal dysfunction (creatinine > 1.5), hepatic disease (known liver disease or aspartate aminotransferase (AST) twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure > 140/90)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo First, then Diclofenac (Arm A); Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.	Drug: Diclofenac; Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks; Other Names: Voltaren; Cataflam; Voltarol; Cambia; Zipsor; Drug: Placebo; Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Experimental: Diclofenac First, then Placebo (Arm B); Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.	Drug: Diclofenac; Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks; Other Names: Voltaren; Cataflam; Voltarol; Cambia; Zipsor; Drug: Placebo; Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Breast Pain	Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.	4 weeks, 10 weeks
Severity of Breast Pain	Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.	4 weeks, 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Days of Pain During the 10 Week Treatment Periods	Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.	Approximately 12 weeks and at 24 weeks after randomization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Robin L. Smith, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 11, 2006
• First Submitted That Met QC Criteria: January 11, 2006
• First Posted (Estimate): January 13, 2006

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 92-05